What will be the next step for the abortion pill?
The Texas Supreme Court’s Case against mifepristone: The Case of Matthew Kacsmaryk, the Alliance Defending Freedom, and a Motion by Dr. Becerra
In Texas, District Judge Matthew Kacsmaryk issued a long-awaited decision on a suit from the Alliance Defending Freedom, which filed on behalf of antiabortion medical groups and doctors against the FDA. Kacsmaryk ruled largely in the group’s favor. He did issue a stay that was supposed to allow the FDA to review the case once it had made a decision. The ruling gave the Department of Justice seven days to seek emergency relief from an appeals court, which it’s already done.
The storm that Kacsmaryk whipped up was evident in heated arguments between Republicans and Democrats. Health and Human Services Secretary Xavier Becerra vowed that women would have safe and effective medication available after the administration launched a legal appeal to stop the suspension from going into force on Friday.
Beyond the dangerous precedent this sets for challenges to other important FDA-approved drugs that some political factions don’t like, the case is an alarming expression of the way right-wing activists are using junk science to bypass the will of the American public and restrict abortion.
Such a move could severely impede a critical arm of the American health care system and deepen acrimony surrounding the regulatory approval process, which was attacked by conservatives amid skepticism of the Covid-19 vaccine.
Some women fear that they will no longer be able to get certain contraceptives because of the removal of a constitutional right to make reproductive health decisions. His comment was a controversial one as it contributed to Republicans’ struggles with female voters.
Abortion opponents, too, view the case as a prime battleground for further reducing women’s opportunities to end a pregnancy. The group of physicians and medical groups sought to have their case heard in Kacsmaryk’s court. A judge in President Donald Trump’s administration previously worked for a conservative Christian legal advocacy group.
Since 2000, when the FDA determined that mifepristone was safe and effective to terminate early pregnancies, government lawyers say, the agency “has consistently adhered to that judgment across five presidential administrations. During that time, more than five million Americans have chosen to end their pregnancies using mifepristone…. When mifepristone is used as FDA directs, serious adverse events are exceedingly rare, just as they are for many common drugs like ibuprofen.”
It is reasonable to ask whether courts should have any say in the scientific decision-making of the F.D.A. The judges have an important job in protecting the ability of the agency to use science and experts to support the health of the Americans. The Texas decision represents a threat to the safety of millions of Americans and it was part of the role that this was.
Monday is the day when the F.D.A finds itself in court. Also on Thursday, Friday and Tuesday. Sometimes the weekends are also. The agency has many dedicated attorneys who defend the actions of the agency. The agency may have missed regulatory deadlines on things such as generic drug approval or whether the agency moved too fast.
Limits on Mifepristone from the New Abortion Mediation Decision in the United States and Implications for Emergency Room Services
Neither the two-drug regime, nor misoprostol-alone medication abortions are available legally in these states. Misoprostol itself remains legal when used for other purposes, like treating ulcers or inducing labor.
The Texas suit claims that the drug was criminalized under federal law because it was intended for abortion. That legal interpretation would limit access to mifepristone because drug suppliers need to ship it to providers.
The new abortion medication dispute now moving up through appellate courts, however, centers on important but dry issues of legal standing, the deadline for filing a lawsuit against the FDA and whether, if the merits of the case are reached, the agency’s actions were arbitrary and capricious.
Some facilities may only offer one medication drug if access to Mifepristone goes away. She said that this would make it more likely that more emergency room visits will be for pain, incomplete abortion and side-effect concerns.
The two-medication protocol can take up to 30 hours to complete, but the Misoprostol-only protocol can be completed in half that time. In the misoprostol-alone regimen, the process usually only takes 9-12 hours, but patients typically experience cramping and bleeding for longer.
The two-drug regimen will usually be given if Mifepristone is still available. If it becomes unavailable, many providers have indicated they’d start prescribing misoprostol alone.
What should consumers know about a ruling ban on abortion drugs? Rep. Nancy Mace of South Carolina, an educator and a pro-life advocate
If the patient experiences heavy bleeding that persists for more than 2 weeks, for example, or bleeds so heavy they need to take two hours to stop, a procedure is needed to complete the abortion.
A high temperature of 100.4 degrees Fahrenheit is a reason to seek medical care. It’s not life threatening if a low grade fever persists for more than 24 hours after taking Misoprostol, but it could be a sign of an illness.
The Food and Drug Administration has approved the two-drug regimen to end pregnancies up to 10 weeks gestational age, but the World Health Organization endorses it up to 12 weeks. After that, they’re less likely to be effective and may cause more bleeding and cramping.
For instance, Mayday. Health offers step-by-step instructions for setting up a mail-forwarding address, so patients can list an address in a permissive state on their intake forms for a telehealth abortion, then get the pills sent along to an additional address somewhere else. Plan C is a website that provides up-to-date information about how to get abortion pills at home.
In her letter to the Food and Drug Administration, the Republican congresswoman who represents a swing district in South Carolina urged them to ignore a judge’s ruling suspending the approval of a medication used for abortion.
This is approved by the FDA. I support the usage of FDA-approved drugs, even if we might disagree,” Rep. Nancy Mace told CNN’s Kaitlan Collins on “This Morning.” “It’s not up to us to decide as legislators or even, you know, as the court system that whether or not this is the right drug to use or not.”
Mace considers herself to be a pro-life person. In the wake of the Supreme Court ruling last year, the party had to navigate a political landscape which imposed harsh restrictions on the procedure.
Tina Smith told CNN that ignoring the ban throws us into another level of chaos, she did not want to know where that ends up.
The case of mifepristone: How to appeal a judge’s ruling on a prescription drug non-availability at midnight
The Justice Department asked a federal appeals court on Monday to put on hold a judge’s ruling that could make a medication abortion drug unavailable nationwide starting Friday at midnight.
This strategy would be especially suitable in this situation because of another court decision issued on 7 April that directly contradicts Kacsmaryk’s orders. In a separate case, a group of 17 states and Washington DC sued the FDA to ease certain restrictions on mifepristone access. Judge Thomas Rice, in the US District Court for the Eastern District of Washington, blocked the FDA from making any changes to reduce the availability of mifepristone in those states. Donley says that the only way the FDA could comply with both conflicting orders would be by exercising its enforcement discretion.
The Justice Department will not be able to appeal the Friday night order for seven days. If the Justice Department doesn’t win a stay from the 5th Circuit, it is expected to appeal to the Supreme Court.
“There was no new evidence that was presented to the court that would change FDA’s determination about whether this product meets the statutory standard for approval,” she adds. “What changed in this case was that ultimately the litigants were able to get their arguments in front of a federal judge.”
State Attorney General Jay Inslee’s Instance on Mifepristone and Federal Appeals to a State Supreme Court Injunction
The governor’s office says they’ve made plans to get an emergency stock of 2 million pills of the drug, which is subject to legal battles in federal courts. Officials say the state currently has more than 250,000 of the pills already on hand, which were purchased for about $100,000.
Meanwhile, Massachusetts Gov. Maura Healy said Monday afternoon that her state has stockpiled some 15,000 mifepristone pills or more than a year’s worth of doses. Last week, Washington Gov. Jay Inslee announced his state had prepared a stockpile of about three years’ worth of mifepristone.
Newsom’s office says the pills were secured through the state’s CalRx prescription drug program, and California is providing information about its purchase agreement to other states that may be interested in taking similar action.
Pharmacies facing shortages will be directed to a state website where they can find information about how to request pills from the misoprostol supply.
Mifepristone has been approved by the US Food and Drug Administration for 23 years, and it has been used by over 5 million women in the United States. The data shows that a small percentage of women taking it have significant adverse events. According to a CNN analysis of FDA data, penicillin and Viagra are riskier than its less risky competitor, mifepristone.
It isn’t clear what will happen next. Appeals have been filed to stop the ruling in Texas from taking hold, and higher courts will have to weigh in.
“Everyone’s eyes are now pointed back towards D.C.,” said Katie Glenn Daniel, the state policy director at Susan B. Anthony Pro-Life America. The Supreme Court will eventually have to weigh in on the merits of this case and the injunctions now being dueled in court.
The Texas lawsuit, filed by a coalition of abortion rights opponents, raised questions about the process by which the FDA originally approved the drug in 2000.
Meanwhile, there’s a competing ruling out of Washington state, where the attorneys general of 17 states and the District of Columbia had sought to force the FDA to expand access to the drug.
(Those states are Arizona, Colorado, Connecticut, Delaware, Hawaii, Illinois, Maine, Maryland, Michigan, Minnesota, Nevada, New Mexico, Oregon, Pennsylvania, Rhode Island, Vermont and Washington.)
Do you need prescriptions? An amicus brief on the reversal of Roe v. Wade by the US Supreme Court
For now, the drug remains available. Kacsmaryk gave the government a week to file an appeal, which is among the legal measures underway to keep the ruling from going into effect. In a case brought by 17 states and the District of Columbia, a judge in Washington state ordered the FDA to keep the drug available.
“For example, if medication is already in pharmacy and has already been prescribed, can those prescriptions be filled?” said David Donatti, an attorney at the ACLU of Texas. “These are questions that the lowest court order just does not answer.”
We hope the Supreme Court resolves it once and for all. It’s been decades in the making,” said Chelsey Youman, an attorney with Human Coalition, an anti-abortion-rights group that filed an amicus brief in the Texas case.
The Supreme Court’s reversal of Roe v. Wade last June was decades in the making, culminating in a dramatic evisceration of women’s constitutional privacy rights and ability to obtain an abortion.
It is going to be working closely with legal advisers in a rapidly changing environment. In the next seven days, the COO of Carafem said that she expected that to be the case.
Patients who were supposed to receive medication abortions next week at Northeast Ohio Women’s Center are being told to change their minds.
It can be used to prevent bleeding between periods and to control hyperstimulation of the ovaries during in-vitro fertilization, the society said in a statement.
On the Role of the Supreme Court in Decisions Concerning the Use of Misoprostol, Mifepristone, and Carafem
In certain circumstances, time is of the essence, says Dr. Alison Edelman, who directs the division of Complex Family Planning at Oregon Health and Sciences University.
The drug has a low risk of major complications, according to the pharma executives letter. A review in the journal of contraception said that a small amount of people who took Mifepristone combined with Misoprostol were hospitalized.
Doctors still have other ways to treat the problems, but they will miss a valuable tool if they ignore the needs of individual patients.
“We have our gold standard of what we provide – the safest, most effective regimen – and then if it’s not available, we use the next best one. Edelman said that they would be left with that.
Carafem has been using only a single regimen since the Covid-19 outbreak began, says the Chief Operating Officer.
“The clinicians would have to use these other options instead of choosing based on their own expertise, knowledge and judgment when rendering such care,” Dr. Iffath Hoskins, president of the American Congress of Obstetricians and Gynecologists, said Monday. I don’t want to be in that position as a clinician.
It would diminish access to abortion even in states that currently allow it if the decision stands. The Supreme Court ruled in the case of Jackson Women’s Health Organization last summer that judges should be out of the abortion business and that the issue should be decided by the states.
Justice Brett Kavanaugh, the apparent key fifth vote in favor of that decision, wrote a separate statement, declaring that judges would no longer decide “difficult moral and policy questions” related to abortion.
He observed that the Supreme Court in its Dobbs decision used the wordfetus in its opinions, but that he favored “unborn human” or “unborn child”.
Editor’s Note: Michele Goodwin is the Chancellor’s Professor of Law at the University of California, Irvine. She wrote a book about the criminalization of motherhood. Mary Ziegler is the Martin Luther King Professor of Law. She is the author of “Roe: The History of a National Obsession” and “Dollars for Life: The Anti-Abortion Movement and the Fall of the Republican Establishment.” The views expressed in this commentary the authors’ own. Do you have an opinion on CNN?
Pro- and anti-abortion lobbyists have filed a lawsuit against the FDA for allegedly violating the FASA P-Birth Abortion Law
DOJ lawyers have argued that the medical groups challenging the FDA lack standing to sue because they have no actual injury and offer baseless speculation regarding harms to women and the medical profession from mifepristone.
Data analyzed by CNN shows mifepristone is even safer than some common, low-risk prescription drugs, including penicillin and Viagra. The risk of death by penicillin, for example, is four times greater than it is for mifepristone, according to a study on life-threatening allergic reactions.
Kacsmaryk contended, however, the FDA had failed to consider “the intense psychological trauma and post-traumatic stress women often experience from chemical abortion.” The FDA had acknowledged the negative effects of the drug, but he maintained it had caused many more deaths.
The DOJ lawyers said Kacsmaryk cherry-picked dubious materials to support his position, and some doctors were quick to try to refute the judge’s medical conclusions.
Voters have sided with the pro-choice side in six out of six times they’ve asked about abortion law, and just last week the Wisconsin Supreme Court ruled against the anti-choice side. A recent Ipsos poll found that nearly two-thirds of Americans want medication abortion to be kept legal.
This strategy underwrote targeted regulations of abortion providers (TRAP laws), onerous clinic regulations and statutes forcing women to receive medically unnecessary and invasive vaginal ultrasounds. Laws requiring waiting periods before a woman can legally end a pregnancy were enacted by state legislatures. This all despite the fact that a woman is about 14 times more likely to die by carrying a pregnancy to term than having an abortion.
When the Supreme Court upheld the federal Partial-Birth Abortion Ban Act in 2007, dubious scientific arguments became even more central to antiabortion advocacy. In the case of scientific uncertainty, the court found that legislators would have more latitude to regulate abortion. That incentivized antiabortion groups to identify or manufacture uncertainty by creating their own data and fielding their own witnesses.
Implausible scientific claims are now visible on social media, in lawsuits and in congressional hearings. In a separate fight, for example, the antiabortion group Students for Life of America has asked the FDA to reconsider its mifepristone approval by making claims about the ill effects of abortion on wastewater.
That Kacsmaryk embraced snake-oil science underscores concerns that broader dangers loom. This case sends a message that challengers don’t need to have science on their side or even the courage to file a lawsuit if his ruling isn’t changed. The control of the courts is all that matters.
Holly Fernandez Lynch, an assistant professor of medical ethics and law at the University of Pennsylvania, calls the Texas ruling “truly an unprecedented decision.”
Why the Texas decision to revoke the FAA’s gold standard is disappointing, and how the FDA can regulate drugs: An analysis of the case of Mifepristone
She tells Morning Edition’s Michel Martin that pharmaceutical companies that develop new products typically conduct clinical trials, evaluate drugs’ safety and effectiveness, and submit a “massive dossier of data” to the FDA, the agency given authority by Congress to determine which products can go to market.
“What has happened in this case from the Northern District of Texas is that we have a single federal judge who has inserted himself, standing in for the agency to say FDA should have never approved mifepristone because they did not have adequate data to determine that it was safe,” Fernandez Lynch says.
The FDA’s former commissioner, who led the agency in 2000 when the drug was first approved, disputes allegations that its approval was fast-tracked.
She acknowledges that the mifepristone was approved under a section of the law that provides for an accelerated process, but denies that safety was compromised.
“The approval process, in terms of looking at all the scientific data, all of the clinical data, the data around how this drug was manufactured followed the normal process of how the FDA reviews every product that it has,” Henney says.
Fernandez Lynch says if judges can weigh in on drug approvals, the pharmaceutical industry could choose to “stick to things that aren’t going to ruffle any feathers.”
Henney also says the Texas ruling is “disappointing” because it not only sends a “very chaotic” message to people seeking abortion care, but could call into question the validity of the FDA process, what she calls the “gold standard” for the U.S. and the world.
“If that is disrupted, it really causes chaos not just in the marketplace, but chaos for medical providers and patients who need a sound and solid voice of authority to say this has been reviewed, these products are safe and effective,” says Henney.
Any prediction of what will happen is speculative at this point. This could have wide-ranging impacts on the entire pharmaceutical industry. So we’ll have to wait and see how it plays out in the appeals courts,” says Donley.
“While PhRMA and our members are not a party to this litigation, our focus is on ensuring a policy environment that supports the agency’s ability to regulate and provides access to FDA-approved medicines,” said the Pharmaceutical Research and Manufacturers of America (PhRMA), which represents the largest biopharmaceutical research companies in the United States, in a statement sent to journalists on request.
Jessica Ellsworth, the lead counsel for Danco, told the media that she was hopeful that the Supreme Court would suspend the decision before April 14.
